Product Development Manager

The Product Development Manager will develop products that meet the standards of relevant regulatory authorities to support animal drug applications for a broad range of dosage types. The Product Development Manager will work closely with the internal and external manufacturing partners and contract manufacturers to ensure the products developed and manufactured meet the expectations of multiple regulatory authorities and meet the organization’s Product Development Goals. The role requires managing outside resources as well as leading project teams.

Qualifications include experience in product development (formulation; analytical methods; process development; or cGMP manufacturing). An advanced degree in pharmaceutical science, chemical engineering or related scientific field with 6+ years industrial drug product development experience.  The successful candidate has experience in the CMC sections of regulatory submissions with strong knowledge of FDA and ICH guidelines, working knowledge of pharmaceutical products including tablets, capsules, parenterals or semisolids. Other qualifications include a broad understanding of API, formulation and manufacturing development, understanding of method validation, stability testing, process validation, quality assurance and regulatory requirements. The successful candidate will have excellent verbal and written communication experience and will enjoy being hands-on with projects and working with colleagues and partners as well as being a self motivated team player. Travel may be required.